FDA recall Z-1019-2019

AAP Implantate Ag · Class II · device

Product

aap Implante AG, Lambotte chisel, 20 mm, REF IU 3000-20 Product Usage: Surgical instruments are intended to aid in the insertion of bone plates and screws as well as for reduction and support during orthopedic surgeries. If not otherwise specified, instruments are intended for multiple use.

Reason for recall

There is the potential for the Lambotte chisel to break at the welded piece parts of the chisel body and knocking plate.

Distribution

Worldwide Distribution - US Nationwide in the state of Texas and country of Germany

Key facts

Status: Terminated
Initiation date: 2019-01-11
Report date: 2019-03-27
Termination date: 2022-05-26
Voluntary/Mandated: Voluntary: Firm initiated
Location: Berlin, N/A, Germany

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1019-2019